Nouvelle déclaration d'incident
No de la demande: 2019-3134
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0022571 (Report 563821)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson Blvd
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: FLORIDA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Small Dog collar (Flumethrin-Imidacloprid)
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Pekingese dog
1
Homme
14
Inconnu
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 08-May-2019, the dog exhibited eyeball protrusion. The dog was evaluated by the veterinarian and no known treatments were performed. On 10-May-2019, the dog died and no necropsy was performed. The intent of the call was to inquire about product use in general and not to report this event. MAH Comment: This collar is suspected counterfeit.
Mort
O - Unclassifiable/unassessable This collar is suspected counterfeit. Nevertheless, for genuine product reported eyeball protrusion is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. No ocular exposure occurred. Other causes are more probable to generic animal, e.g. breed specifics. Further, death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, the intent of the call was to inquire about product use in general and not to report this event. Time to onset is long. Even though, no necropsy performed. Taking into consideration all aspects, especially reported suspected counterfeit, the causality remains unassessable.